Pain Management in Head and Neck Surgery Patients



Status:Recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 69
Updated:3/1/2019
Start Date:November 10, 2017
End Date:November 2020
Contact:Norma Miller, RN
Email:ncmiller@uabmc.edu
Phone:205-934-9714

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Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease
the use and risk of opioid pain medications as well as improve pain control in head and neck
surgery patients. Participants will be randomized to one of two pain regimens (opioid
medication regimen vs combination regimen of opioid and non-opioid medications).

Head and neck surgery patients have significant difficulty with pain control and the
traditional opioid pain regimens can have increased risk in this patients population (namely,
respiratory and airway compromise). Most of the literature for head and neck cancer patients
focuses on pain management during chemoradiation therapy, but very few studies evaluate pain
management in the post-operative setting. Patients with worse pain control and chronic opioid
use do not score as well on quality of life questionnaires and have higher rates of
depression and anxiety.

The few studies that did specifically evaluate post-operative pain showed success with a
scheduled non-opioid management such as NSAIDs, acetaminophen, and gabapentin/pregabalin. In
head and neck surgery patients, pre-operative gabapentin as compared to standard opioid pain
medications was shown to have better pain control and less opioid requirements post
operatively. Post-operative gabapentin has been studied and shows equivalent results, but has
not been tested in a randomized controlled fashion and thus, more data is necessary. In
another study evaluating scheduled acetaminophen vs as needed opioid pain medication in
post-operative Cesarean section patients, there were similar results with improved pain
control and less opioid use. NSAIDS are frequently avoided in post-surgical patients due to
an increased risk of bleeding, but are frequently used in non-surgical patients and have
shown significant benefit in pain control. Celecoxib is an NSAID that does not carry an
increased bleeding risk and has been shown to be beneficial in pain control.

The pain management team in the UAB Department of Anesthesiology currently uses a combination
regimen of opioid and non-opioid medication for their post-operative patients. This is the
combination we plan to use in our treatment group. It consists of the standard dosing of
oxycodone (an opioid) and acetaminophen, gabapentin and celecoxib (non-opioids) and is
considered routine care for Anesthesiology's post-operative patients.

This study would be the first of its kind and potentially help determine a new post-operative
pain management protocol for head and neck patients that is both more effective and less
risky.

Inclusion Criteria:

- age 18-69

- able to consent for themselves

- undergoing a "moderate" head and neck surgery at UAB, defined as procedures that
generally require only 1-2 night stay in the hospital. For the purposes of this
protocol, this will include patients undergoing neck dissections, glossectomy with
primary closure, thyroidectomy, or parotidectomy

Exclusion Criteria:

- age < 18 or > 69

- unable to consent for themselves

- have a known opioid tolerance or are one a home opioid regimen prior to surgery

- known hepatic failure, renal failure, or sulfa allergy, as determined by standard of
care labs drawn within 30 days of enrollment
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-9714
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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from
Birmingham, AL
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